ACS Cath Lab Packs Sterilized with Excess Ethylene Oxide
American Contract Systems recalls ACS Cath Lab Packs distributed in IL, MO, NE, and TX because they were sterilized with higher than specification ethylene oxide concentrations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The sterilization process did not meet specifications, but there is no documented evidence of harm or adverse events.
Plain-English summary
American Contract Systems, Inc. is recalling ACS Cath Lab Packs (Model FTCL83K, Lot 982221) due to a sterilization process defect. The affected packs were distributed in Illinois, Missouri, Nebraska, and Texas.
The product was sterilized with a higher than specification ethylene oxide (EO) concentration, a chemical sterilizing agent used in medical device manufacturing. This sterilization process did not meet the manufacturer's specifications.
The recall affects 10 packs with the Universal Device Identifier (UDI) 00191072151360. Healthcare providers and facilities in the affected states that received these packs should be aware of this recall and should contact American Contract Systems, Inc. for guidance. The FDA has classified this recall as Class II.
The recalled product
- Product
- ACS Cath Lab Pack
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Surgical Supply
- Hazard
- sterilization-defect
- chemical-residue
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model FTCL83K
- Lot 982221 UDI: 00191072151360
Distribution
Distributed nationwide across the United States.
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